GfBS Gesellschaft für Biologische Systematik

Nagoya protocoll and genetic resources: regulations and implementation

The regulations on the utilization of genetic resources, which are intended to prevent biopiracy, do also apply for basic scientific research. To be able to adhere to the relevant national and international regulations, each scientist working with biological material is obliged to acquire the necessary information on these regulations for him- and herself.
Thomas Hörnschemeyer from the Senckenberg Society for Natural Research has compiled several documents concerning this topic:

Important documents and dates

Important date

12th October 2014

EU-regulation 511/2014 applies to all specimens collected or otherwise acquired on or after this day!

EU implementing regulation 2015/1866 is fully active since 9th November 2015

The German law on implementing the EU-regulation 511/2014 becomes effective on 1st Juli 2016.

Instructions

Important regulations for theapplication of the regulations concerning the Nagoya protocoll can be retrieved here:

For those working in Germany or in any other EU member country the EU regulations are the most important documents. Who works or collects specimens in another country must obey the regulations of this country. These regulations can be different from the EU regulations or the Nagoya protocol.

 

 

Handling of genetic material

! EU regulation 511/2014 states that you have to exercise due diligence in acquiring and using genetic resources. It also is necessary to provide documentation of this due diligence and to report to the national authority (in Germany the BfN = Bundesamt für Naturschutz).

A report has to be submitted

  1. if research on genetic resources if funded through public or private grants (Art. 7.1)
  2. during the final phase of development of a product that is based on genetic resources (Art. 7.2)

It is necessary to provide at least the following documents if the regulations in the country, where the genetic source derives from, requires those

PIC – „prior informed consent“
MAT – „mutually agreed terms“ should, at least, contain

  1. A dispute settlement clause
  2. Terms on benefit-sharing, including in relation to intellectual property
  3. Terms on subsequent third-party use, if any
  4. Terms on changes of intent, where applicable

For specimens that will be kept in a collection points iii. and iv. are important to make later use of such specimens by other researchers possible.

The documentation has to be archived for 20 years after utilization of the genetic material has ended!

An important question here is, when utilization of genetic material ends, especially for specimens in a public collection. Eventually, the documentation will have to be archived as long as the specimen exists.

To comply with the documentation requirements, it is necessary to deposit at least copies of all documents connected to biological specimens that have been acquired on or after 12th October 2014 or that will be acquired in the future.

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Updated: 12 July 2016

Updated: 30 June 2016

Published: 11 December 2015